Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML
A Randomized Two-by-Two, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 50 mg or 70 mg Twice Daily or 100 mg or 140 mg Once Daily in Subjects With Chronic Phase Philadelphia Chromosome or BCR-ABL Positive Chronic Myelogenous Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)
1 other identifier
interventional
724
30 countries
131
Brief Summary
This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant to imatinib mesylate (Gleevec).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2005
Longer than P75 for phase_3
131 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 21, 2005
CompletedFirst Posted
Study publicly available on registry
July 25, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
August 26, 2015
CompletedAugust 25, 2016
July 1, 2016
1.2 years
July 21, 2005
June 29, 2015
July 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent of Participants With Major Cytogenetic Response (MCyR) at 6 Months Follow-Up
Cytogenetic response (CyR) was based on the number of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a Bone Marrow (BM) sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): \>0 to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: \>35 to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: \>65 to 95% Ph+ cells in metaphase in BM; No cytogenetic response: \>95 to 100% Ph+ cells in metaphase in BM; Best CyR was defined as the best response obtained at any time during the study; MCyR was defined as a best CyR of complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Baseline=closest to, but no later than, the first day of study drug for treated participants and closest to, but no later than, the date of randomization, for those who were randomized but who never received treatment, unless otherwise specified.
6 months
Secondary Outcomes (21)
Percent of Participants With MCyR At or Prior to 24 Months Follow-Up
24 months
Percent of Participants With Complete Hematologic Response (CHR) at 6 and 24 Months Follow-Up
6 months, 24 months
Time to MCyR in Participants With MCyR at 6 Months Follow-Up
6 months
Time to CHR in Participants With CHR at 6 Months Follow-Up
6 months
Time to MCyR in Participants With MCyR at 24 Months Follow-Up
24 months
- +16 more secondary outcomes
Study Arms (4)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
EXPERIMENTALInterventions
Tablets, Oral, 50 mg BID, indefinitely, survival study
Eligibility Criteria
You may qualify if:
- Subjects with Philadelphia chromosome positive (Ph+) (or BCR/ABL+) chronic phase chronic myeloid leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
- Men and women, 18 years or older
- Adequate hepatic function
- Adequate renal function
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.
You may not qualify if:
- Women who are pregnant or breastfeeding
- Subjects who are eligible and willing to undergo transplantation during the screening period
- A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
- Uncontrolled or significant cardiovascular disease
- Medications that increase bleeding risk
- Medications that change heart rhythms
- Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
- History of significant bleeding disorder unrelated to CML
- Concurrent incurable malignancy other than CML
- Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (137)
University Of Alabama At Birmingham
Birmingham, Alabama, 35294, United States
Central Hematology Oncology Medical Group Inc.
Alhambra, California, 91801, United States
Pacific Cancer Medical Center Inc
Anaheim, California, 92801, United States
Loma Linda University Cancer Center
Loma Linda, California, 92354, United States
Pacific Shores Medical Group
Long Beach, California, 90813, United States
Ucla Dept. Of Medicine
Los Angeles, California, 90095, United States
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030, United States
Kaiser Permanente Medical Center
Vallejo, California, 94589, United States
Georgetown University Med Ctr
Washington D.C., District of Columbia, 20007, United States
Washington Cancer Institute At Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
University Of Florida
Gainesville, Florida, 32610, United States
University Of Miami
Miami, Florida, 33136, United States
Md Anderson Cancer Center Orlando
Orlando, Florida, 32806, United States
Emory University School Of Medicine
Atlanta, Georgia, 30322, United States
Georgia Cancer Specialists
Atlanta, Georgia, 30341, United States
Gwinnett Hospital System Inc.
Lawrenceville, Georgia, 30046, United States
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, 60611, United States
University Of Chicago
Chicago, Illinois, 60637, United States
Oncology Hematology Associates Of Central Illinois, Pc
Peoria, Illinois, 61615, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
University Of Kansas Medical Center
Westwood, Kansas, 66205, United States
University Of Kentucky
Lexington, Kentucky, 40536, United States
University Of Maryland
Baltimore, Maryland, 21201, United States
Dana Faber Cancer Institute
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Washington University School Of Medicine
St Louis, Missouri, 63110, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Devetten, Marcel
Omaha, Nebraska, 68198, United States
Nevada Cancer Institute
Las Vegas, Nevada, 89135, United States
The Cancer Center At Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
The Cancer Institute Of New Jersey
New Brunswick, New Jersey, 08903, United States
New York Presbyterian Hospital
New York, New York, 10021, United States
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, 15224, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Ut Southwestern Medical Center
Dallas, Texas, 75390, United States
The University Of Texas Md Anderson Cancer Center
Houston, Texas, 77030, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Local Institution
La Plata, Buenos Aires, 1900, Argentina
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Buenos Aires, 1221, Argentina
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Capital Federal, 1280, Argentina
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CĂ³rdoba, X5016KEH, Argentina
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Camperdown, New South Wales, 2050, Australia
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St Leonards, New South Wales, 2065, Australia
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South Brisbane, Queensland, 4101, Australia
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Adelaide, South Australia, SA 5000, Australia
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East Melbourne, Victoria, 3002, Australia
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Perth, Western Australia, WA 6000, Australia
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Vienna, 1090, Austria
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B-leuven, 3000, Belgium
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Bruges, 8000, Belgium
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Brussels, 1000, Belgium
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Charleroi, 6000, Belgium
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Edegem, 2650, Belgium
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Yvoir, 5530, Belgium
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Curitiba, ParanĂ¡, 80060, Brazil
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Rio de Janeiro, Rio de Janeiro, 20231, Brazil
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SĂ£o Paulo, SĂ£o Paulo, 05652, Brazil
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CEP - Campinas, 13083, Brazil
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San Paulo, Sp, 05403, Brazil
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Edmonton, Alberta, T6G 1Z2, Canada
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Hamilton, Ontario, L8N 3Z5, Canada
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Montreal, Quebec, H2W 1S6, Canada
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Brno, 625 00, Czechia
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Prague, 128 20, Czechia
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Aarhus C, 8000, Denmark
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Herlev, 2730, Denmark
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Odense C, 5000, Denmark
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Helsinki, 00029, Finland
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Cedex, Pierre Benite, 69495, France
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Caen, 14000, France
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Créteil, 94010, France
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Grenoble, 38043, France
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Lille, 59037, France
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Marseille, 13273, France
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Nantes, 44000, France
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Paris, 75475, France
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Poitiers, 86021, France
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Strasbourg, 67091, France
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Toulouse, 31059, France
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Dresden, 01307, Germany
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Frankfurt am Main, 60590, Germany
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Hamburg, 20246, Germany
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Leipzig, 04103, Germany
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Mainz, 55131, Germany
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Mannheim, 68167, Germany
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Budapest, 1135, Hungary
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Co Galway, Galway, Ireland
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Dublin, 8, Ireland
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Ramat Gan, 52621, Israel
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Bari, 70124, Italy
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Monza (mi), 20052, Italy
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Napoli, 80131, Italy
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Orbassano, 10043, Italy
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Roma, 00144, Italy
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Roma, 00161, Italy
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Distrito Federal, 02990, Mexico
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Nijmegen, 6525 GA, Netherlands
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Rotterdam, 3075 EA, Netherlands
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Trondheim, 7006, Norway
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Lima, Lima Province, 34, Peru
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Jesus Maria, Lima region, 11, Peru
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Quezon City, 1102, Philippines
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Gdansk, 80 211, Poland
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Katowice, 40032, Poland
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Krakow, 31501, Poland
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Lodz, 93510, Poland
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Lublin, 20 950, Poland
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Warsaw, 02097, Poland
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Moscow, 125167, Russia
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Saint Petersburg, 197022, Russia
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Singapore, 169608, Singapore
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Bloemfontein, Free State, 9301, South Africa
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Groenkloof, Gauteng, 0181, South Africa
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Parktown, Gauteng, 2193, South Africa
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Soweto, Gauteng, 2013, South Africa
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Observatory, Western Cape, 7925, South Africa
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Jeollanam-do, 519-809, South Korea
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Kyunggi-do, 480-130, South Korea
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Seoul, 110-744, South Korea
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Seoul, 138-736, South Korea
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Madrid, 28006, Spain
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Madrid, 28034, Spain
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Pamplona, 31008, Spain
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Lund, 22185, Sweden
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Uppsala, 751 85, Sweden
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Basel, 4031, Switzerland
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Taipei, 100, Taiwan
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Taoyuan, 333, Taiwan
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Cambridge, Cambridgeshire, CB2 2XY, United Kingdom
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London, Greater London, W12 OHS, United Kingdom
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Liverpool, Merseyside, L7 8XP, United Kingdom
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Newcastle, Tyne and Wear, NE2 2DR, United Kingdom
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Birmingham, West Midlands, B15 2TH, United Kingdom
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Glasgow, G12 0ZD, United Kingdom
Related Publications (5)
Porkka K, Khoury HJ, Paquette RL, Matloub Y, Sinha R, Cortes JE. Dasatinib 100 mg once daily minimizes the occurrence of pleural effusion in patients with chronic myeloid leukemia in chronic phase and efficacy is unaffected in patients who develop pleural effusion. Cancer. 2010 Jan 15;116(2):377-86. doi: 10.1002/cncr.24734.
PMID: 19924787BACKGROUNDMuller MC, Cortes JE, Kim DW, Druker BJ, Erben P, Pasquini R, Branford S, Hughes TP, Radich JP, Ploughman L, Mukhopadhyay J, Hochhaus A. Dasatinib treatment of chronic-phase chronic myeloid leukemia: analysis of responses according to preexisting BCR-ABL mutations. Blood. 2009 Dec 3;114(24):4944-53. doi: 10.1182/blood-2009-04-214221. Epub 2009 Sep 24.
PMID: 19779040BACKGROUNDShah NP, Kantarjian HM, Kim DW, Rea D, Dorlhiac-Llacer PE, Milone JH, Vela-Ojeda J, Silver RT, Khoury HJ, Charbonnier A, Khoroshko N, Paquette RL, Deininger M, Collins RH, Otero I, Hughes T, Bleickardt E, Strauss L, Francis S, Hochhaus A. Intermittent target inhibition with dasatinib 100 mg once daily preserves efficacy and improves tolerability in imatinib-resistant and -intolerant chronic-phase chronic myeloid leukemia. J Clin Oncol. 2008 Jul 1;26(19):3204-12. doi: 10.1200/JCO.2007.14.9260. Epub 2008 Jun 9.
PMID: 18541900BACKGROUNDShah NP, Rousselot P, Schiffer C, Rea D, Cortes JE, Milone J, Mohamed H, Healey D, Kantarjian H, Hochhaus A, Saglio G. Dasatinib in imatinib-resistant or -intolerant chronic-phase, chronic myeloid leukemia patients: 7-year follow-up of study CA180-034. Am J Hematol. 2016 Sep;91(9):869-74. doi: 10.1002/ajh.24423. Epub 2016 Jun 20.
PMID: 27192969DERIVEDShah NP, Guilhot F, Cortes JE, Schiffer CA, le Coutre P, Brummendorf TH, Kantarjian HM, Hochhaus A, Rousselot P, Mohamed H, Healey D, Cunningham M, Saglio G. Long-term outcome with dasatinib after imatinib failure in chronic-phase chronic myeloid leukemia: follow-up of a phase 3 study. Blood. 2014 Apr 10;123(15):2317-24. doi: 10.1182/blood-2013-10-532341. Epub 2014 Feb 25.
PMID: 24569263DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2005
First Posted
July 25, 2005
Study Start
July 1, 2005
Primary Completion
September 1, 2006
Study Completion
July 1, 2014
Last Updated
August 25, 2016
Results First Posted
August 26, 2015
Record last verified: 2016-07